TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION— 510(k) K130253
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K130253 for TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION, Substantially Equivalent on 2013-07-15. Applicant: Beckman Coulter, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code PER
- Device class
- Class 1
- Regulation
- 21 CFR 862.2750
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code PER
view allMore clearances from Beckman Coulter, Inc.
view allRecalls naming K130253
K-number listed on FDA's recall record- Z-2689-2017 — Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
- Z-2690-2017 — Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130253.
Data sourced from openFDA. This site is unofficial and independent of the FDA.